New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry Recalls are on the rise. How can you avoid them? Analysis shows a 97% increase in the annual number of medical device recalls for the 10-year period, increasing from 604 recalls in FY 2003Read More…

Webinar Announcement Are you done with UDI… or is it just the beginning? Hear directly from FDA’s Senior Advisor for UDI and Industry Experts the profound effect UDI implementation will have on Med-Tech manufacturers, healthcare providers, regulators and ultimately the patient. On Oct. 13th atRead More…

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry Can you distribute poor quality products while complying with all applicable regulatory requirements? Sure! After all, you can conduct a recall of poor quality products in compliance with all applicable regulations. FDA’s Top Medical Device officialRead More…

On Demand Webinar Announced Data integrity and quality are foundational for regulatory compliance and good science, an issue that was recently highlighted by the new “FDA Guidance for Data Integrity and Compliance with cGMP”. This guidance was issued to address a growing number of dataRead More…

By: Daniel R. Matlis, President Improving Healthcare in the Outcome Economy The Internet of Things (IoT) and the transition to the Outcome Economy were key themes at PTC’s LiveWorx16. The focus on IoT and Product Lifecycle Management (PLM) and the shift to outcome based models, sparkedRead More…

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry The Med-Tech industry is obsessed with collecting data, retaining and hoarding it to meet statutory and regulatory requirements. Unfortunately most companies do not harness this data to produce better quality products. As a result, companies suffer fromRead More…

By: Daniel R. Matlis, President Vast Amounts of Process and Product Intelligence Go Unused Life science companies are obsessed with collecting dumb data. We assemble it, retain it, and hoard it to support regulatory and legal requirements. But what happens to these vast amounts of collectedRead More…

Are you done with UDI… or is it just the beginning? Hear directly from FDA’s Senior Advisor for UDI and Industry Experts the profound effect UDI implementation will have on Med-Tech manufacturers, healthcare providers, regulators and ultimately the patient.

On Oct. 13th at 1:30pm Eastern, join Terrie Reed, Senior Advisor for UDI Adoption at the FDA, Daniel R. Matlis of Axendia, and Jean Colombel of Dassault Systemes as they discuss UDI and how its value resides in the ability to optimize meaningful data collection and analysis.

New White Paper: The Future of Change and Configuration Management in the Med-Tech Industry

Can you distribute poor quality products while complying with all applicable regulatory requirements? Sure! After all, you can conduct a recall of poor quality products in compliance with all applicable regulations. FDA’s Top Medical Device official agrees.

Jeff Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health (CDRH), put it this way: “…one device manufacturer can meet FDA requirements and still make a poor quality device; whereas, a second manufacturer may not comply with all FDA requirements and yet make a high-quality device.”

Is your organization focused on Solving Quality Problems or Avoiding Them? Download the white paper to find out how Med-Tech Innovators have been able to shift their focus on improving market presence, manufacturing processes and product quality.

Contact: research@axendia.com to see if you qualify for a complimentary access code and save $499.

Data integrity and quality are foundational for regulatory compliance and good science, an issue that was recently highlighted by the new “FDA Guidance for Data Integrity and Compliance with cGMP”. This guidance was issued to address a growing number of data integrity violations and underscores the importance of data quality and integrity to support intellectual property protection and patient filings in regulated and non-regulated spaces.

The Internet of Things (IoT) and the transition to the Outcome Economy were key themes at PTC’s LiveWorx16. The focus on IoT and Product Lifecycle Management (PLM) and the shift to outcome based models, sparked this analysis on the applicability of these trends in our “sick-care system.”

The traditional healthcare model could better be described as “sick-care.” Historically, healthcare has been episodic and reactive — primarily aimed at addressing a malady, illness or injury after it has already happened.

Here are a few examples:

Have a fever? → Take an antipyretic.

Have an ache? → Take an analgesic.

Have a damaged hip? → Have an arthroplasty.

Have angina? → Have coronary artery bypass graft surgery.

This sick-care approach has it backwards, though. As the refrain goes, an ounce of prevention is worth a pound of cure. Furthermore, sick-care is expensive and unsustainable. But, can we apply the IoT, PLM, and outcome-based models to healthcare? Continue reading →

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